Endovascular delivery system with an improved radiopaque marker scheme

ABSTRACT

An endovascular delivery system for an endovascular prosthesis includes a radiopaque marker system for accurate delivery of the prosthesis. The radiopaque marker system is disposed within a prosthesis or stent holder within the delivery system. The radiopaque marker system includes a plurality of radiopaque markers that provide different views rotation of the prosthesis or stent holder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/970,621, filed Dec. 16, 2015, which is a continuation of U.S. patentapplication Ser. No. 13/803,050, filed Mar. 14, 2013, now U.S. Pat. No.9,233,015, which claims the benefit of U.S. Provisional Application No.61/660,413, filed Jun. 15, 2012, the contents of all of which areincorporated by reference herein.

FIELD OF THE INVENTION

The present invention is related to an endovascular delivery system foran endovascular prosthesis. More particularly, the present invention isrelated to an endovascular delivery system including an improvedradiopaque marker system for accurate delivery of the prosthesis.

BACKGROUND OF THE INVENTION

An aneurysm is a medical condition indicated generally by an expansionand weakening of the wall of an artery of a patient. Aneurysms candevelop at various sites within a patient's body. Thoracic aorticaneurysms (TAAs) or abdominal aortic aneurysms (AAAs) are manifested byan expansion and weakening of the aorta which is a serious and lifethreatening condition for which intervention is generally indicated.Existing methods of treating aneurysms include invasive surgicalprocedures with graft replacement of the affected vessel or body lumenor reinforcement of the vessel with a graft.

Surgical procedures to treat aortic aneurysms can have relatively highmorbidity and mortality rates due to the risk factors inherent tosurgical repair of this disease as well as long hospital stays andpainful recoveries. This is especially true for surgical repair of TAAs,which is generally regarded as involving higher risk and more difficultywhen compared to surgical repair of AAAs. An example of a surgicalprocedure involving repair of a AAA is described in a book titledSurgical Treatment of Aortic Aneurysms by Denton A. Cooley, M.D.,published in 1986 by W.B. Saunders Company.

Due to the inherent risks and complexities of surgical repair of aorticaneurysms, endovascular repair has become a widely-used alternativetherapy, most notably in treating AAAs. Early work in this field isexemplified by Lawrence, Jr. et al. in “Percutaneous Endovascular GraftExperimental Evaluation”, Radiology (May 1987) and by Mirich et al. in“Percutaneously Placed Endovascular Grafts for Aortic Aneurysms:Feasibility Study,” Radiology (March 1989). Commercially availableendoprostheses for the endovascular treatment of AAAs include theAneuRx® stent graft manufactured by Medtronic, Inc. of Minneapolis,Minn., the Zenith® stent graft system sold by Cook, Inc. of Bloomington,Ind., the PowerLink® stent-graft system manufactured by Endologix, Inc.of Irvine, Calif., and the Excluder® stent graft system manufactured byW.L. Gore & Associates, Inc. of Newark, Del. A commercially availablestent graft for the treatment of TAAs is the TAG™ system manufactured byW.L. Gore & Associates, Inc.

When deploying devices by catheter or other suitable instrument, it isadvantageous to have a flexible and low profile stent graft and deliverysystem for passage through the various guiding catheters as well as thepatient's sometimes tortuous anatomy. Many of the existing endovasculardevices and methods for treatment of aneurysms, while representingsignificant advancement over previous devices and methods, use systemshaving relatively large transverse profiles, often up to 24 French.Also, such existing systems have greater than desired lateral stiffness,which can complicate the delivery process. In addition, the sizing ofstent grafts may be important to achieve a favorable clinical result. Inorder to properly size a stent graft, the treating facility typicallymust maintain a large and expensive inventory of stent grafts in orderto accommodate the varied sizes of patient vessels due to varied patientsizes and vessel morphologies. Alternatively, intervention may bedelayed while awaiting custom size stent grafts to be manufactured andsent to the treating facility. As such, minimally invasive endovasculartreatment of aneurysms is not available for many patients that wouldbenefit from such a procedure and can be more difficult to carry out forthose patients for whom the procedure is indicated. What have beenneeded are stent graft systems, delivery systems and methods that areadaptable to a wide range of patient anatomies and that can be safelyand reliably deployed using a flexible low profile system.

SUMMARY OF THE INVENTION

In one embodiment, the present invention is directed to an endovasculardelivery system that includes an elongate outer tubular device having anopen lumen and opposed proximal and distal ends with a medial portiontherein between. Within the outer tubular device, there is a prosthesisholder that may include an axial guidewire extending through the middleof the prosthesis holder and a body surrounding the axial guidewire, thebody including at least two generally cylindrical markers aligned in adirection parallel to the axial guidewire and each spaced an equaldistance from the axial guidewire. The prosthesis holder also includesan outer surface, upon which a prosthesis may be secured prior todelivery.

The present invention also provides a method of delivering a prosthesiswithin a body lumen, which such method includes the step of providing adelivery system. The delivery system includes an elongate outer tubulardevice having an open lumen and opposed proximal and distal ends with amedial portion therein between. The system may also include a prosthesisholder disposed within the outer tubular device. The prosthesis holdermay include an axial guidewire extending through the prosthesis holderand a body surrounding the axial guidewire, the body having at least twogenerally cylindrical markers aligned in a direction parallel to theaxial guidewire and each spaced an equal distance from the axialguidewire. The holder may also include an outer surface and a prosthesissecured to the outer surface. The method then includes the step ofinserting the delivery system within a body lumen and directing theprosthesis holder to a desired location within the lumen. The methodincludes the step of using a known device that provides imaging, such asa radiographic or fluorescopy monitor, to view the location of thegenerally cylindrical markers. The method includes the step of aligningthe prosthesis holder at a rotational angle based upon the generallycylindrical markers and releasing the prosthesis within the body lumen.

In some aspects of the present invention, the endovascular prosthesismay be a modular endovascular graft assembly including a bifurcated maingraft member formed from a supple graft material having a main fluidflow lumen therein. The main graft member may also include anipsilateral leg with an ipsilateral fluid flow lumen in communicationwith the main fluid flow lumen, a contralateral leg with a contralateralfluid flow lumen in communication with the main fluid flow lumen and anetwork of inflatable channels disposed on the main graft member. Thenetwork of inflatable channels may be disposed anywhere on the maingraft member including the ipsilateral and contralateral legs. Thenetwork of inflatable channels may be configured to accept a hardenablefill or inflation material to provide structural rigidity to the maingraft member when the network of inflatable channels is in an inflatedstate. The network of inflatable channels may also include at least oneinflatable cuff disposed on a proximal portion of the main graft memberwhich is configured to seal against an inside surface of a patient'svessel. The fill material can also have transient or chronic radiopacityto facilitate the placement of the modular limbs into the main graftmember. A proximal anchor member may be disposed at a proximal end ofthe main graft member and be secured to the main graft member. Theproximal anchor member may have a self-expanding proximal stent portionsecured to a self-expanding distal stent portion with struts having across sectional area that is substantially the same as or greater than across sectional area of proximal stent portions or distal stent portionsadjacent the strut. At least one ipsilateral graft extension having afluid flow lumen disposed therein may be deployed with the fluid flowlumen of the graft extension sealed to and in fluid communication withthe fluid flow lumen of the ipsilateral leg of the main graft member. Atleast one contralateral graft extension having a fluid flow lumendisposed therein may be deployed with the fluid flow lumen of the graftextension sealed to and in fluid communication with the fluid flow lumenof the contralateral leg of the main graft member. For some embodiments,an outside surface of the graft extension may be sealed to an insidesurface of the contralateral leg of the main graft when the graftextension is in a deployed state. For some embodiments, the axial lengthof the ipsilateral and contralateral legs may be sufficient to provideadequate surface area contact with outer surfaces of graft extensions toprovide sufficient friction to hold the graft extensions in place. Forsome embodiments, the ipsilateral and contralateral legs may have anaxial length of at least about 2 cm. For some embodiments, theipsilateral and contralateral legs may have an axial length of about 2cm to about 6 cm, more specifically, about 3 cm to about 5 cm.

These and other features and advantages of the present invention willbecome apparent from the following detailed description of illustrativeembodiments thereof, which is to be read in connection with theaccompanying drawings. Corresponding reference element numbers orcharacters indicate corresponding parts throughout the several views ofthe drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an initial deployment state of the endovascular deliverysystem of the present invention within a patient's vasculature.

FIG. 2 depicts a deployment state of the endovascular delivery system ofthe present invention within a patient's vasculature after withdrawal ofan outer sheath.

FIG. 3 depicts a deployment state of the endovascular delivery system ofthe present invention within a patient's vasculature after an initialand partial stent deployment.

FIG. 4 depicts a deployment state of the endovascular delivery system ofthe present invention within a patient's vasculature after a stentdeployment.

FIG. 5 depicts a deployed bifurcated endovascular prosthesis with graftleg extensions.

FIG. 6 is a side elevational view of the endovascular delivery system ofthe present invention.

FIG. 7 is a side elevational and partial cutaway view of the distalportion of the endovascular delivery system of the present invention.

FIG. 8 is a partial perspective and partial cutaway view of the distalportion of the endovascular delivery system of the present invention.

FIG. 9 is a schematic representation of the angles formed duringrotation of a delivery system using only one axially aligned radiopaquemarker.

FIG. 10 is a rear perspective view of the prosthesis holder having animproved radiopaque marker system of the present invention.

FIG. 11 is a side view of the prosthesis holder of the presentinvention.

FIG. 12 is a side view of the prosthesis holder of the presentinvention, which has been rotated along its axis.

FIG. 13 is an axial view of the prosthesis holder of the presentinvention

FIG. 14 is a top view of the prosthesis holder of the present invention.

FIG. 15 is a bottom view of the prosthesis holder of the presentinvention.

FIG. 16 is a rear perspective view of the prosthesis holder of thepresent invention.

FIG. 17 is a side view of the prosthesis holder of the presentinvention, which has been axially rotated.

FIG. 18 is a chart depicting the improved gap spacing during rotation ofthe prosthesis.

FIG. 19 is an image of one embodiment of the improved radiopaque markersystem as seen under fluoroscopy in the ipsilateral right position.

FIG. 20 is an image of one embodiment of the improved radiopaque markersystem as seen under fluoroscopy in the anterior-posterior position.

FIG. 21 is an image of one embodiment of the improved radiopaque markersystem as seen under fluoroscopy in the ipsilateral left position.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention are directed generally to methods anddevices for treatment of fluid flow vessels with the body of a patient.Treatment of blood vessels is specifically indicated for someembodiments, and, more specifically, treatment of aneurysms, such asabdominal aortic aneurysms. With regard to graft embodiments discussedherein and components thereof, the term “proximal” refers to a locationtowards a patient's heart and the term “distal” refers to a locationaway from the patient's heart. With regard to delivery system cathetersand components thereof discussed herein, the term “distal” refers to alocation that is disposed away from an operator who is using thecatheter and the term “proximal” refers to a location towards theoperator.

FIG. 1 illustrates an embodiment of a deployment sequence of anembodiment of a endovascular prosthesis (not shown), such as a modulargraft assembly. For endovascular methods, access to a patient'svasculature may be achieved by performing an arteriotomy or cut down tothe patient's femoral artery or by other common techniques, such as thepercutaneous Seldinger technique. For such techniques, a delivery sheath(not shown) may be placed in communication with the interior of thepatient's vessel such as the femoral artery with the use of a dilatorand guidewire assembly. Once the delivery sheath is positioned, accessto the patient's vasculature may be achieved through the delivery sheathwhich may optionally be sealed by a hemostasis valve or other suitablemechanism. For some procedures, it may be necessary to obtain access viaa delivery sheath or other suitable means to both femoral arteries of apatient with the delivery sheaths directed upstream towards thepatient's aorta. In some applications a delivery sheath may not beneeded and the delivery catheter of the present invention may bedirectly inserted into the patient's access vessel by either arteriotomyor percutaneous puncture. Once the delivery sheath or sheaths have beenproperly positioned, an endovascular delivery catheter or system,typically containing an endovascular prosthesis such as but not limitedto an inflatable stent-graft, may then be advanced over a guidewirethrough the delivery sheath and into the patient's vasculature.

FIG. 1 depicts the initial placement of the endovascular delivery system100 of the present invention within a patient's vasculature. Theendovascular delivery system 100 may be advanced along a guidewire 102proximally upstream of blood flow into the vasculature of the patientincluding iliac arteries 14, 16 and aorta 10 shown in FIG. 1. While theiliac arties 14, 16 may be medically described as the right and leftcommon iliac arteries, respectively, as used herein iliac artery 14 isdescribed as an ipsilateral iliac artery and iliac artery 16 isdescribed as a contralateral iliac artery. The flow of the patient'sblood (not shown) is in a general downward direction in FIG. 1. Othervessels of the patient's vasculature shown in FIG. 1 include the renalarteries 12 and hypogastric arteries 18.

The endovascular delivery system 100 may be advanced into the aorta 10of the patient until the endovascular prosthesis (not shown) is disposedsubstantially adjacent an aortic aneurysm 20 or other vascular defect tobe treated. The portion of the endovascular delivery system 100 that isadvance through bodily lumens is desirably a low profile deliverysystem, for example having an overall outer diameter of less than 14French. Other French sizes are also useful, such as but not limited toless than 12 French, less than 10 French, or any sized from 10 to 14French. Once the endovascular delivery system 100 is so positioned, anouter sheath 104 of the endovascular delivery system 100 may beretracted distally so as to expose the prosthesis (not shown) which hasbeen compressed and compacted to fit within the inner lumen of the outersheath 104 of the endovascular delivery system 100.

As depicted in FIG. 2, once the endovascular delivery system 100 is sopositioned, the outer sheath 104 of the endovascular delivery system 100may be retracted distally so as to expose the endovascular prosthesis106 which has been compressed and compacted to fit within the innerlumen of the outer sheath 104 of the endovascular delivery system 100.The outer sheath 104 may be formed of a body compatible material.Desirably, the biocompatible material may be a biocompatible polymer.Examples of suitable biocompatible polymers may include, but are notlimited to, polyolefins such as polyethylene (PE), high densitypolyethylene (HDPE) and polypropylene (PP), polyolefin copolymers andterpolymers, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), polyesters, polyamides, polyurethanes, polyurethaneureas,polypropylene and, polycarbonates, polyvinyl acetate, thermoplasticelastomers including polyether-polyester block copolymers andpolyamide/polyether/polyesters elastomers, polyvinyl chloride,polystyrene, polyacrylate, polymethacrylate, polyacrylonitrile,polyacrylamide, silicone resins, combinations and copolymers thereof,and the like. Desirably, the biocompatible polymers includepolypropylene (PP), polytetrafluoroethylene (PTFE), polyethyleneterephthalate (PET), high density polyethylene (HDPE), combinations andcopolymers thereof, and the like. Useful coating materials may includeany suitable biocompatible coating. Non-limiting examples of suitablecoatings include polytetrafluoroethylene, silicone, hydrophilicmaterials, hydrogels, and the like. Useful hydrophilic coating materialsmay include, but are not limited to, alkylene glycols, alkoxypolyalkylene glycols such as methoxypolyethylene oxide, polyoxyalkyleneglycols such as polyethylene oxide, polyethylene oxide/polypropyleneoxide copolymers, polyalkylene oxide-modified polydimethylsiloxanes,polyphosphazenes, poly(2-ethyl-2-oxazoline), homopolymers and copolymersof (meth) acrylic acid, poly(acrylic acid), copolymers of maleicanhydride including copolymers of methylvinyl ether and maleic acid,pyrrolidones including poly(vinylpyrrolidone) homopolymers andcopolymers of vinyl pyrrolidone, poly(vinylsulfonic acid), acryl amidesincluding poly(N-alkylacrylarnide), poly(vinyl alcohol),poly(ethyleneimine), polyamides, poly(carboxylic acids), methylcellulose, carboxymethylcellulose, hydroxypropyl cellulose,polyvinylsulfonic acid, water soluble nylons, heparin, dextran, modifieddextran, hydroxylated chitin, chondroitin sulphate, lecithin,hyaluranon, combinations and copolymers thereof, and the like.Non-limiting examples of suitable hydrogel coatings include polyethyleneoxide and its copolymers, polyvinylpyrrolidone and its derivatives;hydroxyethylacrylates or hydroxyethyl(meth)acrylates; polyacrylic acids;polyacrylamides; polyethylene maleic anhydride, combinations andcopolymers thereof, and the like. Desirably, the outer sheath 104 may bemade of polymeric materials, e.g., polyimides, polyester elastomers(Hytrel®), or polyether block amides (Pebax®), polytetrafluoroethylene,and other thermoplastics and polymers. The outside diameter of the outersheath 104 may range from about 0.1 inch to about 0.4 inch. The wallthickness of the outer sheath 104 may range from about 0.002 inch toabout 0.015 inch. The outer sheath 104 may also include an outerhydrophilic coating. Further, the outer sheath 104 may include aninternal braided portion of either metallic or polymeric filaments. Inaddition to being radially compressed when disposed within an innerlumen of the outer sheath 104 of the endovascular delivery system 100, aproximal stent 108 may be radially restrained by high strength flexiblebelts 110 in order to maintain a small profile and avoid engagement ofthe proximal stent 108 with a body lumen wall until deployment of theproximal stent 108 is initiated. The belts 110 can be made from any highstrength, resilient material that can accommodate the tensilerequirements of the belt members and remain flexible after being set ina constraining configuration. Typically, belts 110 are made from solidribbon or wire of a shape memory alloy such as nickel titanium or thelike, although other metallic or polymeric materials are possible. Belts110 may also be made of braided metal filaments or braided or solidfilaments of high strength synthetic fibers such as Dacron®, Spectra orthe like. An outside transverse cross section of the belts 110 may rangefrom about 0.002 to about 0.012 inch, specifically, about 0.004 to about0.007 inch. The cross sections of belts 21, 22 and 23 may generally takeon any shape, including rectangular (in the case of a ribbon), circular,elliptical, square, etc. The ends of the belts 110 may be secured by oneor more stent release wires or elongate rods 112 which extend throughlooped ends (not shown) of the belts 110. The stent release wires orelongate rods 112 may be disposed generally within the prosthesis 106during delivery of the system 100 to the desired bodily location. Forexample, the stent release wires or elongate rods 112 may enter and exitthe guidewire lumen 122 or other delivery system lumen as desired toaffect controlled release of the stent 108, including if desiredcontrolled and staged release of the stent 108. Once the outer sheath104 of the endovascular delivery system 100 has been retracted, theendovascular delivery system 100 and the endovascular prosthesis 106 maybe carefully positioned in an axial direction such that the proximalstent 108 is disposed substantially even with the renal arteries.

Desirably, the endovascular prosthesis 106 includes an inflatable graft114. The inflatable graft may be a bifurcated graft having a main graftbody 124, an ipsilateral graft leg and a contralateral graft leg 128.The inflatable graft 114 may further include a fill port 116 in fluidcommunication with an inflation tube of the endovascular delivery system100 for providing an inflation medium (not shown). The distal portion ofthe endovascular delivery system 100 may include a nosecone 120 whichprovides an atraumatic distal portion of the endovascular deliverysystem 100. The guidewire 102 is slidably disposed within a guidewirelumen 122 of the endovascular delivery system 100.

As depicted in FIG. 3, deployment of the proximal stent 108 may beginwith deployment of the distal portion 130 of stent 108 by retracting thestent release wire or rod 112 that couples ends of belt 110 restrainingthe distal portion 130 of the stent 108. The distal portion 130 of stent108 may be disposed to the main graft body 124 via a connector ring 142.The stent 108 and/or the connector ring 142 may be made from or includeany biocompatible material, including metallic materials, such as butnot limited to, nitinol, cobalt-based alloy such as Elgiloy, platinum,gold, stainless steel, titanium, tantalum, niobium, and combinationsthereof. The present invention, however, is not limited to the use ofsuch a connector ring 142 and other shaped connectors for securing thedistal portion 130 of the stent 108 at or near the end of the main graftbody 124 may suitably be used. Additional axial positioning maytypically be carried out even after deploying the distal portion 130 ofthe stent 108. This may still be carried out in many circumstances asthe proximal portion 132 of the stent 108 does not include tissueengaging barbs (not shown) for some embodiments and will provide onlypartial outward radial contact or frictional force on the inner lumen ofthe patient's vessel or aorta 10 until the proximal portion 132 of thestent 108 is deployed. Once the belt 110 constraining the proximalportion 132 of the stent 108 has been released, the proximal portion 132of the stent 108 self-expands in an outward radial direction until anoutside surface of the proximal portion 132 of the stent 108 makescontact with and engages an inner surface of the patient's vessel 10.

As depicted in FIG. 4, after the distal portion 130 of the stent 108 hasbeen deployed, the proximal portion 132 of the stent 108 may then bedeployed by retracting the wire 112 that couples the ends of the belt110 restraining the proximal portion 132 of the stent 108. As theproximal portion 132 of the stent 108 self-expands in an outward radialdirection, an outside surface of the proximal portion 132 of the stent108 eventually makes contact with the inside surface of the patient'saorta 10. For embodiments that include tissue engaging barbs (not shown)on the proximal portion 132 of the stent 108, the barbs may also beoriented and pushed in an outward radial direction so as to make contactand engage the inner surface tissue of the patient's vessel 10, whichfurther secures the proximal stent 108 to the patient's vessel 10.

Once the proximal stent 108 has been secured to the inside surface ofthe patient's vessel 10, the proximal inflatable cuff 134 may then befilled through the inflation port 116 with inflation material injectedthrough an inflation tube 118 of the endovascular delivery system 100which may serve to seal an outside surface of the inflatable cuff 134 tothe inside surface of the vessel 10. The remaining network of inflatablechannels 136 are also filled with pressurized inflation material at thesame time which provides a more rigid frame like structure to theinflatable graft 114. For some embodiments, the inflation material maybe a curable or hardenable material that may cured or hardened once thenetwork of inflatable channels 136 are filled to a desired level ofmaterial or pressure within the network. Some embodiments may alsoemploy radiopaque inflation material to facilitate monitoring of thefill process and subsequent engagement of graft extensions (not shown).The material may be cured by any of the suitable methods discussedherein including time lapse, heat application, application ofelectromagnetic energy, ultrasonic energy application, chemical addingor mixing or the like. Some embodiments for the inflation material thatmay be used to provide outward pressure or a rigid structure from withinthe inflatable cuff 134 or network of inflatable channels 136 mayinclude inflation materials formed from glycidyl ether and aminematerials. Some inflation material embodiments may include an in situformed hydrogel polymer having a first amount of diamine and a secondamount of polyglycidyl ether wherein each of the amounts are present ina mammal or in a medical device, such as an inflatable graft, located ina mammal in an amount to produce an in situ formed hydrogel polymer thatis biocompatible and has a cure time after mixing of about 10 seconds toabout 30 minutes and wherein the volume of said hydrogel polymer swellsless than 30 percent after curing and hydration. Some embodiments of theinflation material may include radiopaque material such as sodiumiodide, potassium iodide, barium sulfate, Visipaque 320, Hypaque,Omnipaque 350, Hexabrix and the like. For some inflation materialembodiments, the polyglycidyl ether may be selected fromtrimethylolpropane triglycidyl ether, sorbitol polyglycidyl ether,polyglycerol polyglycidyl ether, pentaerythritol polyglycidyl ether,diglycerol polyglycidyl ether, glycerol polyglycidyl ether,trimethylolpropane polyglycidyl ether, polyethylene glycol diglycidylether, resorcinol diglycidyl ether, glycidyl ester ether of p-hydroxybenzoic acid, neopentyl glycol diglycidyl ether, 1,6-hexanedioldiglycidyl ether, bisphenol A (PO)₂ diglycidyl ether, hydroquinonediglycidyl ether, bisphenol S diglycidyl ether, terephthalic aciddiglycidyl ester, and mixtures thereof. For some inflation materialembodiments, the diamine may be selected from (poly)alkylene glycolhaving amino or alkylamino termini selected from the group consisting ofpolyethylene glycol (400) diamine, di-(3-aminopropyl) diethylene glycolr, polyoxypropylenediamine, polyetherdiamine, polyoxyethylenediamine,triethyleneglycol diamine and mixtures thereof. For some embodiments,the diamine may be hydrophilic and the polyglycidyl ether may behydrophilic prior to curing. For some embodiments, the diamine may behydrophilic and the polyglycidyl ether is hydrophobic prior to curing.For some embodiments, the diamine may be hydrophobic and thepolyglycidyl ether may be hydrophilic prior to curing.

The network of inflatable channels 136 may be partially or fullyinflated by injection of a suitable inflation material into the mainfill port 116 to provide rigidity to the network of inflatable channels136 and the graft 114. In addition, a seal is produced between theinflatable cuff 134 and the inside surface of the abdominal aorta 10.Although it is desirable to partially or fully inflate the network ofinflatable channels 136 of the graft 114 at this stage of the deploymentprocess, such inflation step optionally may be accomplished at a laterstage if necessary.

Once the graft 114 is anchored and the inflatable channels 136 thereofhave been filled and expanded, another delivery catheter (not shown) maybe used to deploy a contralateral graft extension 138, as depicted inFIG. 5. The contralateral graft extension 138 is in an axial positionwhich overlaps the contralateral leg 128 of the graft 114. The amount ofdesired overlap of the graft extension 138 with the contralateral leg128 may vary depending on a variety of factors including vesselmorphology, degree of vascular disease, patient status and the like.However, for some embodiments, the amount of axial overlap between thecontralateral graft extension 138 and the contralateral leg 128 may beabout 1 cm to about 5 cm, more specifically, about 2 cm to about 4 cm.Once the contralateral graft extension 138 has been deployed, anipsilateral graft extension may be similarly deployed in the ipsilateralgraft leg 126.

For some deployment embodiments, the patient's hypogastric arteries maybe used to serve as a positioning reference point to ensure that thehypogastric arteries are not blocked by the deployment. Upon such adeployment, the distal end of a graft extension 138 or 140 may bedeployed anywhere within a length of the ipsilateral leg 126 orcontralateral leg 128 of the graft 114. Also, although only one graftextension 140, 138 is shown deployed on the ipsilateral side andcontralateral side of the graft assembly 114, additional graftextensions 140, 138 may be deployed within the already deployed graftextensions 140, 138 in order to achieve a desired length extension ofthe ipsilateral leg 126 or contralateral leg 128. For some embodiments,about 1 to about 5 graft extensions 138, 140 may be deployed on eitherthe ipsilateral or contralateral sides of the graft assembly 114.Successive graft extensions 138, 140 may be deployed within each otherso as to longitudinally overlap fluid flow lumens of successive graftextensions.

Graft extensions 138, 140, which may be interchangeable for someembodiments, or any other suitable extension devices or portions of themain graft section 124 may include a variety of suitable configurations.For some embodiments, graft extensions 138, 140 may include apolytetrafluoroethylene (PTFE) graft 142 with helical nitinol stent 144.

Further details of the endovascular prosthesis 106 and/or graftextensions 138, 140 may be found in commonly owned U.S. Pat. Nos.6,395,019; 7,081,129; 7,147,660; 7,147,661; 7,150,758; 7,615,071;7,766,954 and 8,167,927 and commonly owned U.S. Published ApplicationNo. 2009/0099649, the contents of all of which are incorporated hereinby reference in their entirety. Details for the manufacture of theendovascular prosthesis 106 may be found in commonly owned U.S. Pat.Nos. 6,776,604; 7,090,693; 7,125,464; 7,147,455; 7,678,217 and7,682,475, the contents of all of which are incorporated herein byreference in their entirety. Useful inflation materials for theinflatable graft 114 may be found in may be found in commonly owned U.S.Published Application No. 2005/0158272 and 2006/0222596, the contents ofall of which are incorporated herein by reference in their entirety.Additional details of an endovascular delivery system having abifurcated and inflatable prosthesis having a tether from acontralateral leg to restrain movement of the contralateral leg withrespect to an ipsilateral leg of the prosthesis may be found in commonlyowned U.S. Provisional Application No. 61/660,105, entitled “BifurcatedEndovascular Prosthesis Having Tethered Contralateral Leg”, filed onJun. 15, 2012, the contents of which are incorporated the herein byreference in their entirety. Additional details of an endovasculardelivery system including an improved hypotube may be found in commonlyowned U.S. Provisional Application No. 61/660,103, entitled“Endovascular Delivery System With Flexible And Torqueable Hypotube”,filed on Jun. 15, 2012, the contents of which are incorporated theherein by reference in their entirety.

Useful graft materials for the endovascular prosthesis 106 include, butare not limited, polyethylene; polypropylene; polyvinyl chloride;polytetrafluoroethylene (PTFE); fluorinated ethylene propylene;fluorinated ethylene propylene; polyvinyl acetate; polystyrene;poly(ethylene terephthalate); naphthalene dicarboxylate derivatives,such as polyethylene naphthalate, polybutylene naphthalate,polytrimethylene naphthalate and trimethylenediol naphthalate;polyurethane, polyurea; silicone rubbers; polyamides; polyimides;polycarbonates; polyaldehydes; polyether ether ketone; natural rubbers;polyester copolymers; silicone; styrene-butadiene copolymers;polyethers; such as fully or partially halogenated polyethers; andcopolymers and combinations thereof. Desirably, the graft materials arenon-textile graft materials, e.g., materials that are not woven,knitted, filament-spun, etc. that may be used with textile grafts. Suchuseful graft material may be extruded materials. Particularly usefulmaterials include porous polytetrafluoroethylene without discerniblenode and fibril microstructure and (wet) stretched PTFE layer having lowor substantially no fluid permeability that includes a closed cellmicrostructure having high density regions whose grain boundaries aredirectly interconnected to grain boundaries of adjacent high densityregions and having substantially no node and fibril microstructure, andporous PTFE having no or substantially no fluid permeability. PTFElayers lacking distinct, parallel fibrils that interconnect adjacentnodes of ePTFE and have no discernible node and fibril microstructurewhen viewed at a scanning electron microscope (SEM) magnification of20,000. A porous PTFE layer having no or substantially no fluidpermeability may have a Gurley Number of greater than about 12 hours, orup to a Gurley Number that is essentially infinite, or too high tomeasure, indicating no measurable fluid permeability. Some PTFE layershaving substantially no fluid permeability may have a Gurley Number at100 cc of air of greater than about 10⁶ seconds. The Gurley Seconds isdetermined by measuring the time necessary for a given volume of air,typically, 25 cc, 100 cc or 300 cc, to flow through a standard 1 squareinch of material or film under a standard pressure, such as 12.4 cmcolumn of water. Such testing maybe carried out with a GurleyDensometer, made by Gurley Precision Instruments, Troy, N.Y. Details ofsuch useful PTFE materials and methods for manufacture of the same maybe found in commonly owned U.S. Patent Application Publication No.2006/0233991, the contents of which are incorporated herein by referencein their entirety.

FIG. 6 is a side elevational view of the endovascular delivery system100 of the present invention. The endovascular delivery system 100 mayinclude, among other things, the nosecone 120; the outer sheath 104; aretraction knob or handle 152 for the outer sheath 104; a flush port 154for the outer sheath 104; an outer sheath radiopaque marker band 156; aninner tubular member 150; an inflation material or polymer fillconnector port 158; an inflation material or polymer fill cap 160; aguidewire flush port 162; a guidewire flush port cap 164; a guidewireport 166; and nested stent release knobs 168; interrelated as shown.

The flush port 154 for the outer sheath 104 may be used to flush theouter sheath 104 during delivery stages. The outer sheath 104 may have aradiopaque marker band to aid the practitioner in properly navigatingthe delivery system 100 to the desired bodily site. The outer sheath 104is retractable by movement of the retraction knob or handle 152 for theouter sheath 104 by a practitioner towards the proximal handle assembly170 of the delivery system 100. The inner tubular member 150 is disposedfrom the inner tubular member 150 toward a proximal portion of thedelivery system 100. The inflation material or polymer fill connectorport 158 and the inflation material or polymer fill cap 160 are usefulfor providing inflation material or polymer fill material to inflateproximal inflatable cuffs 134 and the network of inflatable channels 136of the inflatable graft 114. The guidewire flush port 162 and theguidewire flush port cap 164 are useful for flushing the guidewire port166 during delivery stages of the delivery system 100. The nested stentrelease knobs 168 contains a series of nested knobs (not shown) thatthat are used to engage release mechanisms for delivery of theendovascular prosthesis 106. Further details, including but not limitedto methods, catheters and systems, for deployment of endovascularprostheses are disclosed in commonly owned U.S. Pat. Nos. 6,761,733 and6,733,521 and commonly owned U.S. Patent Application Publication Nos.2006/0009833 and 2009/0099649, all of which are incorporated byreference herein in their entirety.

FIG. 7 is a side elevational and partial cutaway view of the distalportion 172 of the endovascular delivery system 100 of the presentinvention, and FIG. 8 is a partial perspective and partial cutaway viewof the distal portion 172 of the endovascular delivery system 100 of thepresent invention. The distal portion 172 of the endovascular deliverysystem 100 includes a prosthesis/stent holder 174 disposed upon aprosthesis/stent holder guidewire 176. The holder 174 is usefulreleasably securing the endovascular prosthesis 106 (not shown) withinthe delivery system 100. The holder 174 inhibits or substantiallyinhibits undesirable longitudinal and/or circumferential movement of theendovascular prostheses 106 during delivery stages of the deliverysystem 100. Belts 110 serve to restrain the endovascular prosthesis 106in a radially constrained stage until desired release of theendovascular prosthesis 106.

During delivery of the prosthesis 106, the physician implanting thedevice will insert the device into the patient, using a series ofradiopaque markers to align the prosthesis in the appropriate location.Typical delivery devices, however, sometimes use radiopaque markers inthe prosthesis itself to aid in proper placement of the device in thebody. Use of radiopaque markers in the prosthesis itself can beinsufficient due to the inherent radiopacity of some prostheses thatmakes identification and differentiation of such radiopaque markersdifficult.

FIG. 9 demonstrates an advantage of an embodiment of the currentinvention that includes two markers 200 and 202, which can beradiopaque. FIG. 9 is a cross sectional schematic view of a prosthesisdelivery device along a longitudinal axis of guidewire 176, showing afirst marker 200 and a second marker 202. During delivery of aprosthesis using this embodiment, the physician implanting the devicetypically views one or more images of the prosthesis and its deliverysystem, including markers 200 and 202, via fluoroscopy, which providesan image of the delivery system from a perspective that is generallyperpendicular to the longitudinal axes of the delivery system andguidewire 176, as seen by the depiction of an eyesight in FIG. 9. Asdepicted in the FIG. 9 schematic, the direction of eyesight is along theaxis y. Guidewire 176 may be made of a radiopaque material. As can beseen, there is a gap 204 as seen in the projection in the view along they axis between the first marker 200 and the second marker 202. Inperfect axial/rotational alignment with the line of sight of the user(i.e., wherein a rotational angle θ, defined as that angle formedbetween marker 200 or 202 and either an x or y axis, as seen in the FIG.9, is defined to be zero), the gap 204 is at its maximum. As can be seenin FIG. 9, as the device is rotated along the guidewire 176 longitudinalaxis away from this position, the gap 204 becomes smaller. The radialseparation of each marker 200, 202 (in the case of marker 202, it beingthe radial separation as measured to the outermost portion fromguidewire 176), is depicted with the symbol “R”. The gap 204 between thefirst marker 200 and second marker 202 is denoted as R cos θ−R sin θ.Notably, without a second marker 202, the gap is denoted as R cos θ(ignoring the small effect of the width of guidewire 176).

To allow the physician to achieve the most precise desiredrotational/circumferential alignment of the prosthesis at the intendedθ=0 position, gap 204 may be as large as possible. Thus, during deliveryof the prosthesis, the physician implanting the device may rotate theprosthesis until the gap between the markers is at its largest. Vascularbodies within an individual may not have perfect symmetry along theguidewire 176 axis, or alternatively, along the axis of the catheterlumen, and a vascular prosthesis may be configured accordingly. As such,the placement of a prosthesis within these vascular bodies may requireprecise and accurate rotational alignment; that is, alignment of thedevice circumferentially along its longitudinal axis. Even a smallmisalignment may result in defective placement within the vascular bodyor complicate and/or lengthen the delivery procedure, which could resultin negative clinical outcomes and/or increased costs associated with theprocedure. For example, cannulation of the contralateral limb aperture(gate) may be adversely affected if the device is not oriented properly.Proper orientation of the device, for example, allows the aortic bodylimbs to be positioned laterally, facilitating access to thecontralateral gate via a guidewire/catheter inserted into the patient'scontralateral access vessels.

With respect to second marker 202 of the embodiment depicted in FIG. 9,the rate of change of gap 204 as a function of rotational angle of thecatheter can be denoted as the “gap equation”:d _(gap) /dθ=−R(sin θ+cos θ),while in the case of a system without a second marker as configured inembodiments described herein the rate of change of the gap can bedenoted as:d _(gap) /dθ=−R sin θ.

For some embodiments, when the prosthesis 106 is positioned correctlyfor optimum deployment (θ is approximately zero), d_(gap)/dθ is about−R, a relatively large value which indicates a strong sensitivity to gapwidth as a function of rotational angle (in contrast, for the case of asystem containing a single marker, d_(gap)/dθ=0; i.e., there is novariation or sensitivity of gap 204 width to rotational angle θ). For asituation in which a small angular error exists; for example, if θ isabout 0.1 radians (about 6° rotated), then d_(gap)/dθ is approximately11 times greater with embodiments containing two markers as compared tosystems containing a single marker case.

Accordingly, some embodiments contain at least one, and desirably two,additional markers, each disposed approximately at a +/−90° angle from afirst marker as measured from the longitudinal axis of guidewire 176.Although the Figures show axially aligned tubular markers, usefulmarkers may simply be dots, squares, or bars that radiate from thecenter of the device. Desirably, the markers are oriented as far awayfrom the center of the device as possible, to maximize the gap betweenthe axis (and thus the guidewire) and the marker. In embodiments thatuse two or three such markers, each offset by approximately 90° relativeto a first marker as described above, greater than eleven times therotational sensitivity to the gap may be afforded to the physicianimplanting the prosthesis, thus allowing significantly more control inthe alignment of the prosthesis during implantation. Such embodimentssolve or mitigate problems with systems having a single marker asoutlined above, because by virtue of the additional markers being offsetby approximately 90° at least one of the markers will always be in aposition to contribute high rotational angle sensitivity during theprosthesis implantation procedure (i.e., either the sine, or cos θ termin the “gap equation” will be operative). This allows the physician tohave improved prosthesis placement sensitivity during its implantation,and particular, increased placement sensitivity when performing anyrotational maneuvers during the implantation procedure.

An improved radiopaque marker system may be useful for the user toaccurately deliver a prosthesis. The device may include a series ofmarkers, as will be described below. The description below includes aseries of markers in one component of the delivery system, specificallythe prosthesis holder. However, it will be understood that the markersystem described herein may be useful in any portion of the deliverysystem, including, for example, the sheath or nosecone. In addition, thedelivery system may include a separate component including the markersystem and the purpose of this separate component is to provide themarker system to the delivery system.

FIGS. 10-17 show an embodiment of an improved radiopaque marker systemas described herein. FIG. 10 shows a rear and front perspective view ofcomponents of the system, respectively. A prosthesis/stent holderguidewire 176 extends through a central lumen 184 disposed inprosthesis/stent holder 174, thus forming a longitudinal axis of lumen184 that is coincident with a longitudinal axis of guidewire 176 when soconfigured. Further, in the embodiment depicted in FIG. 10, theprosthesis/stent holder guidewire 176 fully extends through theprosthesis/stent holder lumen 184 such that the prosthesis/stent holderguidewire is exposed at each end of the prosthesis/stent holder 174.

Guidewire 176 may be made of any desired material. In one embodiment,guidewire 176 is made from a material that is viewable via radiography,fluoroscopy or other visualization techniques. For example, suchmaterials may be metal, such as palladium, iridium, gold, tantalum,tungsten, platinum, and combinations thereof. The material may be apolymeric material, such as a radiopaque nylon. Alternatively, thematerial may include fillers that are radiopaque, such as bismuth,barium, and tungsten. Although the present invention contemplates usinga guidewire 176 to aid in placement of the prosthesis, the use of theguidewire 176 for final placement is optional. That is, the guidewire176 could be retracted, or not used at all, and the markers in theprosthesis/stent holder 174 can be used to provide guidance as to theproper rotational alignment of the prosthesis.

Within the body of the prosthesis/stent holder 174 of the embodimentshown in FIG. 10, there is a series of three axially aligned markers178A, 178B, 178C, which are all parallel to the axis formed by the axialguidewire 176. Although the three axially aligned markers 178A, 178B,178C are depicted in the Figures as being generally cylindrical, it isunderstood that any suitable markers may be used, including, forexample, dots or a series of dots, or bars. The three axially alignedmarkers 178A, 178B, 178C are positioned at approximately 90° intervalsaround the circumference of the prosthesis/stent holder 174 andseparated from the prosthesis/stent holder guidewire 176 by a suitableknown distance. The three axially aligned markers 178A, 178B, 178C insome embodiments are each of the same length and the same diameter,although some variation in sizing may occur. Further, each of the threeaxially aligned markers 178A, 178B, 178C are separated from theprosthesis/stent holder guidewire 176 by the same distance, thuscreating the same gap size therebetween.

Markers 178A, 178B, 178C may be made from any desired material visiblewith imaging modality used in a deployment procedure, including aradiopaque material, such as platinum, iridium, palladium, gold,tantalum, tungsten, radiopaque nylon, bismuth, barium, tungsten orcombinations thereof. In some embodiments, each of the three axiallyaligned markers 178A, 178B, 178C are made from the same material,although it is not necessary. In one particular embodiment, markers178A, 178B, 178C are made from a combination of 90% by weight platinumand 10% by weight iridium. Markers 178A, 178B, 178C may be the same ordifferent shape, and may be cylindrical as shown in FIG. 10; however,any other suitable symmetric or asymmetric shape may be used for one ormore of the markers, including, for example, rectangular prisms, bars,cubes, spheres, split cylinders and half-moon shapes. One or more ofmarkers 178A, 178B, 178C may be of a hollow, partially hollow, or solidconstruction. In addition, there may be one physical marker, which hasseparate elements secured to each other and spaced apart to create a gapbetween elements. In addition, there may be more than three markers, solong as there is at least two elements disposed approximately 90° fromeach other. For example, there may be more than four or five markers inthe device. In addition, the markers may be a series of discontinuousmarkers, such as spheres or cubes, which create the ability to view thegap 186 upon rotation of the device.

In embodiments using a guidewire 176, diameter D176 of theprosthesis/stent holder guidewire 176 may be equal to or larger than thediameter D178A, D178B, D178C of each of the three axially alignedmarkers 178A, 178B, 178C. Thus, during implantation, if the device isproperly aligned relative to its intended transverse viewing direction,the two side axially aligned markers 178A, 178C will be visuallysuperimposed along with the guidewire 176, and a maximum gap will bevisible between collinear markers 178A, 178C and center marker 178B. Insome embodiments, the diameter of the prosthesis/stent holder guidewire176 may be from about 0.010 inches to about 0.060 inches, orapproximately 0.030 to about 0.050 inches, and the diameter of each ofthe three axially aligned markers 178A, 178B, 178C is approximately0.010 inches to about 0.060 inches, or approximately 0.020 inches toabout 0.030 inches.

The prosthesis/stent holder 174 may optionally include one or more thanone markers 180A, 180B which may be radiopaque and are disposed suchthat their axial length along a direction that is approximately 90°(perpendicular) to the axis of the prosthesis/stent holder guidewire176. These markers 180A, 180B may be made from the same material as thethree axially aligned markers 178A, 178B, 178C and/or theprosthesis/stent holder guidewire 176, or may be made from a differentradiopaque material. Markers 180A, 180B may be cylindrical in shape, butmay take any desired shape as described for markers 178A-C. Inclusion ofmarkers 180A, 180B is optional, as they further aid in the alignment ofthe prosthetic device.

The prosthesis/stent holder 174 in the embodiment shown in FIGS. 10-17includes a series of crown anchors 182 that secure the prosthesis/stentin place before and during implantation. The crowns of the prostheticstent (not shown) may be secured around the crown anchors 182, thuspreventing rotational movement of the stent before and duringimplantation. The prosthesis/stent holder 174 and crown anchors 182 maybe made from any desired material, including a non-radiopaque materialto allow a physician to more readily visualize the radiopaque markersand the guidewire 176 during implantation.

Markers 178A, 178B, 178C, 180A and 180B may be formed and assembled intothe system by any suitable means. One or more of the markers may bepress fitted into the prosthesis/stent holder 174; alternatively, one ormore of the markers may be molded into the prosthesis/stent holder 174,so that they are fully or partially encapsulated within the materialcomprising holder 174. In some embodiments, one or more of the markersmay be press fitted and secured with a suitable adhesive, such as a UVor cyanoacrylate adhesive.

FIG. 11 shows a side view of the prosthesis/stent holder 174 of theembodiment shown in FIG. 10. The side view of FIG. 11 is at a viewingangle whereby the longitudinal axes of markers 178A and 178C arevisually aligned in an overlapping manner with the longitudinal axis ofguidewire 176 disposed within lumen 184 of holder 174. This view may be,for example, a view that a physician will have when implanting theprosthesis in the vasculature under, e.g., fluoroscopy. For purposes ofdescribing features of this embodiment, one may consider this a baselineconfiguration in which there has been no rotation of theprosthesis/stent holder 174 relative to the line of sight of the user,indicated in FIGS. 10 and 13 (that is, 0 is zero).

In the FIG. 11 view, a gap 186 is visible between an outer surface orcircumference of the second axially aligned marker 178B and the surfaceof prosthesis/stent holder guidewire 176. The projection of the gap 186as viewed by the user along the sight of axis y is measured between theouter surface or circumference of the guidewire 176 and the outersurface of the second axially aligned marker 178B. As explained above,during the prosthesis implantation procedure under visualization such asfluoroscopy, when the system is rotated such that this projection of thegap 186 is maximized so that the physician will be able to tell that theprosthesis is in the desired rotational alignment. Also, as can be seen,when the device is rotated as shown in the view of FIG. 11, markers178A, 178C are visually aligned with the prosthesis/stent holderguidewire 176 such that they largely or completely overlap. Underfluorescopy, then, markers 178A, 178C cannot readily be seen in thisalignment, since the guidewire 176 is wider than the markers 178A, 178Cin this particular embodiment.

In the rotational configuration shown in FIG. 11, gap 186 is at itslargest. The gap 186 as viewed by the user in this configuration may beas large as possible, which is dependent upon the size of the catheterused. In order to maximize the gap 186, the marker diameter D178 may bekept to as minimum as possible while still allowing the user to view themarker 178 via imaging device. If the material from which the markers178 are made is extremely radiopaque, a smaller or thinner marker 178may be used and still provide the user with visibility with an imagingdevice. A radiopaque marker 178 may have a diameter of from about 0.010inches to about 0.050 inches, or from about 0.020 inches to about 0.040inches. For example, depending upon the radius of the catheter, the gapmay have a size of about 0.010 to about 0.080 inches. A gap space fortypical prosthetic systems such as those described herein may be fromabout 0.020 to about 0.065 inch, or may be from about 0.035 to about0.055 inches. However, a larger gap may be used to provide the user withease of viewing even with lower quality imaging systems or lessradiopaque materials.

FIG. 12 shows the system of FIG. 11 that has been rotated in a clockwisedirection about guidewire 176 longitudinal axis by approximately 10°. Ascan be seen, markers 178A, 178B, 178C have all now been rotatedclockwise. A portion of marker 178C would now be visible in this viewunder, e.g., fluoroscopy, as extending slightly above the boundary orouter surface of guidewire 176. Similarly, a portion of marker 178Awould now be visible as extending in this view slightly below theboundary or outer surface of guidewire 176. Marker 178B now appears tobe closer to the guidewire 176 when viewed from this angle as the lengthof gap 186 is now smaller compared to its length in the direct alignmentview of FIG. 11. Due to the presence of both the first axially alignedmarker 178A and the second axially aligned marker 178B, the gap 186 isaffected to a greater degree even with a small rotation of theprosthesis/stent holder 174. This greater reduction in gap 186 sizeduring rotation of the device compared to systems with a single markeror a different configuration allows for greater precision duringimplantation. In addition, through the use of three markers 178A, 178B,178C, the gap 186 may be minimized whether the device is turned in theclockwise or counterclockwise direction.

FIG. 13 shows a view of the prosthesis/stent holder 174 transverse toits longitudinal axis and longitudinal axis of its lumen 184 and thecoincident longitudinal axis of guidewire 176 (extending in a normaldirection out of the plane of the page). As can be seen and aspreviously described with respect to FIG. 10, guidewire 176 extendsthrough lumen 184 of the prosthesis/stent holder 174. Also as previouslydescribed, three axially aligned markers 178A, 178B and 178C aredisposed around the guidewire 176, which may be spaced at approximately90° intervals and at an equal distance from the guidewire 176.Projection of the gap 186, described with respect to the views of FIGS.11 and 12, is also shown.

FIG. 14 shows the prosthesis/stent holder 174 as viewed from the top andFIG. 15 shows the prosthesis/stent holder 174 as viewed from the bottom(both relative to the orientation of the components in the FIG. 13view). Notably, when viewed from the bottom, in direct alignment, themiddle marker 178B, even if radiopaque, would be difficult or impossibleto visualize by a deploying physician under, e.g., fluoroscopy, as it isshielded from view by a radiopaque guidewire 176.

FIGS. 16 and 17 show a front perspective view and side view,respectively, after the prosthesis/stent holder 174 has been rotatedslightly. As can be seen, the angles and gaps formed by the surface ofguidewire 176 and the surfaces of axially aligned markers 178A, 178B,178C are changed due to the rotation of the prosthesis/stent holder 174.

FIG. 18 is a chart depicting the change in the gap 186 between theguidewire 176 and an axially aligned marker 178A, 178B, or 178C,depending upon the angle of rotation, as an embodiment of theprosthesis/stent holder 174 is rotated about its longitudinal axis. Thechart shows the change in the gap (using three axially aligned markers178A, 178B, 178C) as compared to the change of an identically-definedgap in a device that uses only one axially aligned marker (e.g., 178B)during identical rotation. As can be seen, in the inventive design, thesize of gap 186 is reduced at a greater rate than in a device using onemarker for a given angle of rotation. To reduce the gap 186 toapproximately zero under visualization, the prosthesis/stent holder 174need only be rotated about 22 degrees. In a device using only oneaxially aligned marker, however, the prosthesis/stent holder need berotated about 50 degrees. Thus, the inventive design provides asignificantly greater degree of accuracy during rotation than otherdevices. Any shape or layout of markers 178A, 178B, 178C may be used,including, as explained above, continuous markers such as cylinders ordiscontinuous markers such as a series of dots, spheres, cubes, and thelike. In addition, in one embodiment, different shaped markers may beused in the same device, to allow the user to be able to differentiatebetween the markers in the device and allow for even greater precision.For example, marker 178A can be a series of spherical dots, while marker178C can be a series of cubes. As the device is rotated and the relativemarkers 178A, 178C can be seen by the user, the difference in shape mayallow the user to have even greater control and precision.

The present invention may be used to deliver any desired devices,including stents, stent grafts, and the like. Bifurcated and fenestrateddevices may be implanted using the present invention. The device may beused to aid in placement of devices in other locations, including, forexample, in cranial implantation. Further, although the presentinvention is quite useful in aiding alignment when viewed from the sideangle, the device may also be useful in providing alignment in axial orquasi-axial views. Various elements of the device create angles and gapsupon rotation when viewed from different angles, and thus the presentinvention may be useful in various other embodiments.

The inventive device has been explained with reference to theprosthesis/stent holder 174, but it is noted that the axially alignedmarker system explained herein may be useful in other locations andother components of the delivery device.

In one embodiment, a device is prepared for implantation including theprosthesis/stent holder 174 described above, with a stent-graftprosthesis secured to the prosthesis/stent holder 174. The stent-graftprosthesis is secured to the prosthesis/stent holder 174 as explainedabove and the delivery device is prepared for implantation.

In some embodiments, a method of delivering and implanting a prosthesisis provided. In this embodiment, the delivery device, includingprosthesis/stent holder 174 as explained above, is provided. Thedelivery device includes a prosthesis secured thereto, such as astent-graft. The user, typically a physician, inserts the deliverydevice into the patient's body, more particularly, into the desiredbodily lumen into which the prosthesis is to be implanted. The physicianuses fluoroscopy to view radiopaque materials in the delivery device andprosthesis on a display device. As the device is being directed to itsdesired location, the physician views the location of the device via thedisplay, which shows the presence of various radiopaque markers withinthe body.

When the prosthesis is at the desired location, the physician may thenadjust the rotation of the device to ensure properrotational/circumferential alignment. As explained above, there is a gapbetween the axially aligned radiopaque markers 178 and theprosthesis/stent holder guidewire 176. Using an anterior/posteriorfluoroscopic view, for example, the physician rotates the prosthesisuntil the gap between the axially aligned radiopaque markers 178 and theprosthesis/stent holder guidewire 176 is at its largest and on theintended side of the guidewire 176. At this gap size, the prosthesis isin proper rotational alignment, and the prosthesis may be implanted withgreater confidence that might otherwise be possible. After implantation,the delivery device is withdrawn. In embodiments where multipleprosthetic parts are being implanted together, one or more of theadditional prosthetic parts may employ the improved radiopaque markersystem as explained above, thereby ensuring properrotational/circumferential placement of each prosthetic part.

FIGS. 19-21 show various positions of a radiopaque marker system of thepresent invention, as seen under fluoroscopy. FIG. 19 shows the devicein the ipsilateral right position, FIG. 20 shows the device in theanterior-posterior position, and FIG. 21 shows the device in theipsilateral left position. As can be seen in FIGS. 19 and 21, the middlemarker is visible, while the two side markers are superimposed on theradiopaque guidewire. The two perpendicular markers are clearly visible.Also, as can be seen, there is a visible gap between the middle markerand the guidewire. FIG. 20 is oriented such that the middle marker issuperimposed on the guidewire, while the two side markers are visible.

The following embodiments or aspects of the invention may be combined inany fashion and combination and be within the scope of the presentinvention, as follows:

Embodiment 1

An endovascular delivery system, comprising:

-   -   an elongate outer tubular device having an open lumen and        opposed proximal and distal ends with a medial portion therein        between;    -   a prosthesis holder disposed within said outer tubular device,        said prosthesis holder comprising:        -   an axial guidewire extending through said prosthesis holder        -   a body surrounding said axial guidewire, said body            comprising at least two generally cylindrical markers            aligned in a direction parallel to said axial guidewire and            each spaced an equal distance from said axial guidewire; and        -   an outer surface, upon which a prosthesis may be secured            prior to delivery.

Embodiment 2

The delivery system of embodiment 1, wherein said prosthesis holder ismade of a material that is not fluorescent or radiopaque.

Embodiment 3

The delivery system of embodiment 1, wherein said axial guidewire ismade of a material that is fluorescent or radiopaque.

Embodiment 4

The delivery system of embodiment 1, wherein each of said generallycylindrical markers are made of a material that is fluorescent orradiopaque.

Embodiment 5

The delivery system of embodiment 4, wherein each of said generallycylindrical markers are made of a combination of platinum and iridium.

Embodiment 6

The delivery system of embodiment 1, further comprising a thirdgenerally cylindrical marker aligned in a direction parallel to saidaxial guidewire, wherein each of said generally cylindrical markers isspaced an equal distance from said axial guidewire.

Embodiment 7

The delivery system of embodiment 6, wherein each of said generallycylindrical markers are spaced at about 90° intervals as measured aroundthe axis formed by the axial guidewire.

Embodiment 8

The delivery system of embodiment 7, wherein each of said generallycylindrical markers are made of a material that is fluorescent orradiopaque.

Embodiment 9

The delivery system of embodiment 8, wherein each of said generallycylindrical markers are made of a combination of platinum and iridium.

Embodiment 10

The delivery system of embodiment 1, further comprising at least oneperpendicular marker, wherein said perpendicular marker is disposed at aperpendicular angle to the axial guidewire.

Embodiment 11

The delivery system of embodiment 10, wherein said perpendicular markeris made of a material that is fluorescent or radiopaque.

Embodiment 12

The delivery system of embodiment 11, wherein said perpendicular markeris made of a combination of platinum and iridium.

Embodiment 13

The delivery system of embodiment 6, further comprising at least oneperpendicular marker, wherein said perpendicular marker is disposed at aperpendicular angle to the axial guidewire.

Embodiment 14

The delivery system of embodiment 13, wherein said perpendicular markeris made of a material that is fluorescent or radiopaque.

Embodiment 15

The delivery system of embodiment 14, wherein said perpendicular markeris made of a combination of platinum and iridium.

Embodiment 16

The delivery system of embodiment 1, wherein said prosthesis is astent-graft.

Embodiment 17

The delivery system of embodiment 16, wherein said prosthesis holdercomprises a plurality of anchors to secure said stent-graft to saidouter surface of said prosthesis holder.

Embodiment 18

The delivery system of embodiment 1, wherein said generally cylindricalmarkers are press-fitted into said body.

Embodiment 19

The delivery system of embodiment 1, wherein said generally cylindricalmarkers are molded into said body.

Embodiment 20

The delivery system of embodiment 1, wherein said generally cylindricalmarkers have a diameter of about 0.030 inches.

Embodiment 21

The delivery system of embodiment 1, wherein said axial guidewire has adiameter of about 0.035 inches.

Embodiment 22

The delivery system of embodiment 6, wherein said generally cylindricalmarkers are press-fitted into said body.

Embodiment 23

The delivery system of embodiment 6, wherein said generally cylindricalmarkers are molded into said body.

Embodiment 24

The delivery system of embodiment 6, wherein said generally cylindricalmarkers have a diameter of about 0.010 to about 0.040 inches.

Embodiment 25

The delivery system of embodiment 6, wherein said axial guidewire has adiameter of about 0.010 to about 0.050 inches.

Embodiment 26

The delivery system of embodiment 1, wherein each of said generallycylindrical markers are disposed in said body at a distance of about0.010 inches to about 0.015 inches from said axial guidewire.

Embodiment 27

The delivery system of embodiment 6, wherein each of said generallycylindrical markers are disposed in said body at a distance of about0.010 inches to about 0.015 inches from said axial guidewire.

Embodiment 28

A method of delivering a prosthesis within a body lumen, comprising thesteps of:

-   -   (a) providing a delivery system comprising:        -   (i) an elongate outer tubular device having an open lumen            and opposed proximal and distal ends with a medial portion            therein between; and        -   (ii) a prosthesis holder disposed within said outer tubular            device, said prosthesis holder comprising:            -   an axial guidewire extending through said prosthesis                holder            -   a body surrounding said axial guidewire, said body                comprising at least two generally cylindrical markers                aligned in a direction parallel to said axial guidewire                and each spaced an equal distance from said axial                guidewire;            -   an outer surface; and            -   a prosthesis secured to said outer surface;    -   (b) inserting said delivery system within a body lumen and        directing said prosthesis holder to a desired location within        the lumen;    -   (c) using a device to view the location of the generally        cylindrical markers;    -   (d) aligning said prosthesis holder at a rotational angle based        upon the generally cylindrical markers; and    -   (e) releasing said prosthesis within said body lumen.

Embodiment 29

The method of embodiment 28, wherein said prosthesis holder is made of amaterial that is not fluorescent or radiopaque.

Embodiment 30

The method of embodiment 28, wherein said axial guidewire is made of amaterial that is fluorescent or radiopaque.

Embodiment 31

The method of embodiment 28, wherein each of said generally cylindricalmarkers are made of a material that is fluorescent or radiopaque.

Embodiment 32

The method of embodiment 31, wherein each of said generally cylindricalmarkers are made of a combination of platinum and iridium.

Embodiment 33

The method of embodiment 28, further comprising a third generallycylindrical marker aligned in a direction parallel to said axialguidewire, wherein each of said generally cylindrical markers is spacedan equal distance from said axial guidewire.

Embodiment 34

The method of embodiment 33, wherein each of said generally cylindricalmarkers are spaced at about 90° intervals as measured around the axisformed by the axial guidewire.

Embodiment 35

The method of embodiment 34, wherein each of said generally cylindricalmarkers are made of a material that is fluorescent or radiopaque.

Embodiment 36

The method of embodiment 35, wherein each of said generally cylindricalmarkers are made of a combination of platinum and iridium.

Embodiment 37

The method of embodiment 28, further comprising at least oneperpendicular marker, wherein said perpendicular marker is disposed at aperpendicular angle to the axial guidewire.

Embodiment 38

The method of embodiment 37, wherein said perpendicular marker is madeof a material that is fluorescent or radiopaque.

Embodiment 37

The method of embodiment 38, wherein said perpendicular marker is madeof a combination of platinum and iridium.

Embodiment 38

The method of embodiment 33, further comprising at least oneperpendicular marker, wherein said perpendicular marker is disposed at aperpendicular angle to the axial guidewire.

Embodiment 39

The method of embodiment 38, wherein said perpendicular marker is madeof a material that is fluorescent or radiopaque.

Embodiment 40

The method of embodiment 39, wherein said perpendicular marker is madeof a combination of platinum and iridium.

Embodiment 41

The method of embodiment 28, wherein said prosthesis is a stent-graft.

Embodiment 42

The method of embodiment 41, wherein said prosthesis holder comprises aplurality of anchors to secure said stent-graft to said outer surface ofsaid prosthesis holder.

Embodiment 43

The method of embodiment 28, wherein said generally cylindrical markersare press-fitted into said body.

Embodiment 44

The method of embodiment 28, wherein said generally cylindrical markersare molded into said body.

Embodiment 45

The method of embodiment 28, wherein said generally cylindrical markershave a diameter of about 0.030 inches.

Embodiment 46

The method of embodiment 28, wherein said axial guidewire has a diameterof about 0.035 inches.

Embodiment 47

The method of embodiment 33, wherein said generally cylindrical markersare press-fitted into said body.

Embodiment 48

The method of embodiment 33, wherein said generally cylindrical markersare molded into said body.

Embodiment 49

The method of embodiment 33, wherein said generally cylindrical markershave a diameter of about 0.030 inches.

Embodiment 50

The method of embodiment 33, wherein said axial guidewire has a diameterof about 0.035 inches.

Embodiment 51

The method of embodiment 28, wherein each of said generally cylindricalmarkers are disposed in said body at a distance of about 0.010 inches toabout 0.015 inches from said axial guidewire.

Embodiment 52

The method of embodiment 33, wherein each of said generally cylindricalmarkers are disposed in said body at a distance of about 0.010 inches toabout 0.015 inches from said axial guidewire.

Embodiment 53

The method of embodiment 28, wherein said device comprises a monitor toview radiographic or fluorescent materials.

Embodiment 54

The method of embodiment 53, wherein said monitor reads an image thelumen of a patient at an angle that is perpendicular to the axis formedby the axial guidewire.

Embodiment 55

The method of embodiment 54, wherein said step (d) of aligning saidprosthesis holder at a rotational angle based upon the cylindricalmarkers comprises the steps of:

-   -   (i) viewing said monitor;    -   (ii) measuring the size of the distance between the generally        cylindrical markers and the axial guidewire; and    -   (iii) rotating said prosthesis holder until the distance between        the generally cylindrical markers and axial guidewire is at its        largest.

While various embodiments of the present invention are specificallyillustrated and/or described herein, it will be appreciated thatmodifications and variations of the present invention may be effected bythose skilled in the art without departing from the spirit and intendedscope of the invention. Further, any of the embodiments or aspects ofthe invention as described in the claims or in the specification may beused with one and another without limitation.

What is claimed is:
 1. An endovascular delivery system, comprising: anelongate outer tubular device having an open lumen and opposed proximaland distal ends with a medial portion therein between; an inner tubularmember disposed within said outer tubular device, said inner tubularmember comprising a proximal portion comprising: a rotatable prosthesisholder comprising a body surrounding an axial guidewire, said bodycomprising a plurality of markers; and an outer surface, upon which aprosthesis may be secured prior to delivery, wherein the plurality ofmarkers comprises a first generally cylindrical marker having alongitudinal axis aligned in a direction parallel to said axialguidewire and a second generally cylindrical marker having alongitudinal axis aligned in a direction perpendicular to said axialguidewire.
 2. The endovascular delivery system of claim 1, wherein saidfirst generally cylindrical marker and said second generally cylindricalmarker are spaced an equal distance from said axial guidewire.
 3. Theendovascular delivery system of claim 1, wherein said prosthesis holderis made of a material that is not fluorescent or radiopaque.
 4. Theendovascular delivery system of claim 1, wherein said axial guidewire ismade of a material that is fluorescent or radiopaque.
 5. Theendovascular delivery system of claim 1, wherein said first and secondgenerally cylindrical markers are made of a material that is fluorescentor radiopaque.
 6. The endovascular delivery system of claim 1, whereinat least a portion of said first generally cylindrical marker isdisposed within a first interior portion of the body of the prosthesisholder.
 7. The endovascular delivery system of claim 1, wherein at leasta portion of said second generally cylindrical marker is disposed withina second interior portion of the body of the prosthesis holder.
 8. Theendovascular delivery system of claim 1, wherein said first generallycylindrical marker and/or said second generally cylindrical marker aremade of materials selected from the group consisting of palladium,iridium, gold, tantalum, tungsten, platinum, and combinations thereof.9. The endovascular delivery system of claim 1, wherein said firstgenerally cylindrical marker and/or said second generally cylindricalmarker are made of radiopaque polymeric materials.
 10. The endovasculardelivery system of claim 9, wherein said radiopaque polymeric materialscomprise polymeric materials with radiopaque fillers.
 11. Theendovascular delivery system of claim 10, wherein said radiopaquefillers are selected from the group consisting of bismuth, barium, andtungsten.
 12. The endovascular delivery system of claim 1, wherein saidfirst generally cylindrical marker and said second generally cylindricalmarker are spaced at about a 90° interval as measured around alongitudinal axis formed by said axial guidewire.
 13. The endovasculardelivery system of claim 1, wherein said first generally cylindricalmarker and said second generally cylindrical marker comprise a shapeselected from the group consisting of a hollow construction, a partiallyhollow construction and a solid construction.
 14. The endovasculardelivery system of claim 1, wherein a first interior portion of the bodyof the prosthesis holder is different from a second interior portion ofthe body of the prosthesis holder.
 15. A method of delivering aprosthesis within a body lumen comprising: providing the endovasculardelivery system of claim 1; providing a prosthesis securably disposed tothe outer surface of said prosthesis holder; inserting said endovasculardelivery system within a body lumen and directing said prosthesis holderto a desired location within the lumen; using a device to view thelocation of said plurality of markers; aligning said prosthesis holderat a rotational angle based upon a position of at least one marker ofthe plurality of markers; and releasing said prosthesis within said bodylumen.
 16. The method of claim 15, comprising aligning said prosthesisholder at a rotational angle based on the position of the firstgenerally cylindrical marker and the second generally cylindricalmarker.
 17. The method of claim 15, comprising aligning said prosthesisholder at a rotational angle θ based upon the position of said firstgenerally cylindrical marker and said second generally cylindricalmarker until θ is about zero, where θ refers to an angle between saidfirst generally cylindrical marker and said second generally cylindricalmarker from an axis generally perpendicular from the longitudinal axisformed by said axial guidewire.
 18. The method of claim 15 comprisingaligning said prosthesis holder at a rotational angle θ based upon theposition of said first generally cylindrical marker and said secondgenerally cylindrical marker until dgap/dθ is about −R, where θ refersto an angle between said first generally cylindrical marker and saidsecond generally cylindrical marker from an axis generally perpendicularfrom the longitudinal axis formed by said axial guidewire, R refers toradial separation of a marker as measured to its outermost portion fromsaid axial guidewire, the value of the gap is R cos θ−R sin θ, anddgap/dθ=R(sin θ+cos θ).